Intraaortic Balloon Pump in Cardiogenic Shock II - Full Text View

Sponsored by:	University of Leipzig
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00491036

Purpose

Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only.

Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration. The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.

Condition	Intervention
Myocardial Infarction Shock, Cardiogenic	Device: Intraaortic balloon pump

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

mortality [ Time Frame: 30 day ]

Secondary Outcome Measures:

Key secondary endpoint(s): hemodynamic parameters, catecholamine dose, APACHE-II-score, inflammatory markers, serum lactate Assessment of safety: major bleeding complications, peripheral ischemic vascu-lar complications [ Time Frame: 30 days ]

Study Start Date:	January 2008
Estimated Study Completion Date:	August 2010

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with:
- Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole and
- Signs of pulmonary congestion
Signs of impaired organ perfusion:
- Altered mental status
- Cold, clammy skin
- Urine output <30 ml/h
- Serum lactate >2mmol/l
Hemodynamic parameters:
- Cardiac index  2,0 l/min/m2
- PCWP > 15 mmHg
Informed consent

Exclusion Criteria:

Resuscitation > 30 minutes
Cerebral deficit with fixed dilated pupils
No intrinsic heart action
Mechanical infarction complication
Onset of shock > 12 h
Severe peripheral artery disease
Massive lung emboli
Aortic regurgitation > II.°
Age > 90 years
Other severe concomitant disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491036

Contacts

Contact: Holger Thiele, MD

+49 341 8651426

thielh@medizin.uni-leipzig.de

Sponsors and Collaborators

University of Leipzig

Investigators

Study Chair:

Holger Thiele, MD

University of Leipzig

More Information

No publications provided

Study ID Numbers:	342
Study First Received:	June 22, 2007
Last Updated:	June 22, 2007
ClinicalTrials.gov Identifier:	NCT00491036 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

Acute myocardial infarction
cardiogenic shock
percutaneous coronary intervention
intraaortic balloon counterpulsation
Acute myocardial infarction – cardiogenic shock

Study placed in the following topic categories:

Necrosis
Heart Diseases
Shock
Shock, Cardiogenic
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Shock, Cardiogenic
Shock
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009